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A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

ConditionsAdvanced Solid Tumors CancerMSI-H Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNimbus Wadjet, Inc.

About this trial

The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.

The main questions it aims to answer are:

Is NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size?

Participants will:

Take NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone.

Keep a diary of their tablet consumption and symptoms experienced.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Have unresectable and/or metastatic solid tumors (with or without MSI-H/dMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists

Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)

Adequate bone marrow / hematologic, end-organ, and cardiovascular function

Disqualifiers

Clinically significant cardiovascular disease.

Patients with known WRN syndrome.

Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NDI-219216

    Drug

    NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.

Treatment groups

134 Participants
are divided into 3 treatment groups
Group A: Part A dose escalationExperimental treatment 1 intervention
Group B: Part B Project OptimusExperimental treatment 1 intervention
Group C: Part C Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A Primary Objective: Incidence of dose limiting toxicities (DLTs)

Assessments will include electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation)

Time frame
The first 21 days of Cycle 1 (Cycle 1 is 28 days).
2

Part A Primary Outcome: • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), according to NCI CTCAE v5.0

Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation.

Time frame
From first dose of study drug until 30 days after last dose of study drug; up to approximately 11-12 months. Each Cycle is 28 days.
3

Part A Primary Outcome: Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events (TRAEs) as assessed by the Investigator

Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation).

Time frame
From first dose of study drug until 30 days after last dose of study drug; up to approximately 11-12 months. Each Cycle is 28 days.
4

Part B Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.

Time frame
From start of study treatment until end of follow-up, up to approximately 18 months. Each Cycle is 28 days.

Secondary outcomes

1

Part A Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.

Time frame
At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
2

Part A Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216

Time frame
At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
3

Part A Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216

Time frame
At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
4

Part A Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216

Time frame
At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nimbus Wadjet, Inc.

Lead sponsor

Worldwide Clinical Trials

Collaborator

Source ClinicalTrials.gov
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